Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07497321
NA

Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)

Sponsor: A.M.I. Agency for Medical Innovations GmbH

View on ClinicalTrials.gov

Summary

The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation. The primary objective is to verify the treatment outcome and success of the ProGYNious mesh implant in pelvic organ prolapse repair. The secondary objective is to confirm the safety, risks, complications and quality of life of ProGYNious as an implant for pelvic organ prolapse repair.

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-04-15

Completion Date

2028-09-30

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DEVICE

Surgical mesh for pelvic organ prolapse repair (ProGYNious)

Implantation of a pelvic floor mesh implant for laparoscopic sacrocolpopexy

Locations (5)

Universitätsklinikum Wiener Neustadt, Klinik für Gynäkologie und Geburtshilfe

Wiener Neustadt, Lower Austria, Austria

Kardinal Schwarzenberg Klinikum

Schwarzach im Pongau, Salzburg, Austria

Universitätsklinikum Erlangen, Frauenklinik

Erlangen, Bavaria, Germany

Klinik Agatharied, Gynäkologie & Geburtshilfe

Hausham, Bavaria, Germany

Universitätsmedizin Frankfurt, Klinik für Gynäkologie und Geburtshilfe

Frankfurt am Main, Hesse, Germany